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EN 14683
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EN 14683

EN 14683:2019+AC:2019 is the European standard for medical face masks (surgical masks). It defines requirements for bacterial filtration efficiency (BFE), breathability, fit, and optionally splash resistance.

Three mask types are defined:

  • Type I: BFE ≥95 %, no splash resistance test – suitable for general patient protection
  • Type II: BFE ≥98 %, no splash resistance test
  • Type IIR: BFE ≥98 % + passed splash resistance test – required for surgical procedures

Medical face masks under EN 14683 are Class I medical devices under MDR (EU) 2017/745. Their purpose is to protect the environment (patient, sterile field) from droplet and splash transmission by the wearer – not to protect the wearer from inhalation.

For personal respiratory protection of the wearer (e.g. against aerosols), FFP masks per EN 149 are required. EN 14683 and EN 149 have different test methods and protection objectives and must not be equated.

Frequently asked questions

What is the difference between EN 14683 Type I, Type II, and Type IIR?

Type I: BFE ≥95 % – basic protection, no splash test. Type II: BFE ≥98 % – higher filtration, no splash test. Type IIR: BFE ≥98 % + splash resistance – required for surgical procedures involving blood or fluid exposure.

Does an EN 14683 mask protect the wearer from infection?

No. Medical face masks per EN 14683 protect the environment from the wearer's microbial transmission. Personal respiratory protection for the wearer requires an FFP mask per EN 149.

Are medical face masks medical devices or PPE?

Medical face masks under EN 14683 are Class I medical devices under MDR (EU) 2017/745, not PPE. PPE respiratory masks (FFP) per EN 149 are PPE Category III.